Targeted opioid receptor antagonists in the treatment of alcohol use disorders

CNS Drugs

Volumn 27, Issue 10, 2013, Pages 777-787

  Niciu, Mark J ^a,b   Arias, Albert J ^a  

^a VA CONNECTICUT HEALTHCARE SYSTEM   (United States)

^b NATIONAL INSTITUTE OF MENTAL HEALTH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

MU OPIATE RECEPTOR; NALMEFENE; NALTREXONE; OPIATE ANTAGONIST;

ALCOHOLISM; ARTICLE; DRINKING BEHAVIOR; DRUG APPROVAL; DRUG EFFICACY; DRUG TARGETING; FOOD AND DRUG ADMINISTRATION; GENETIC VARIABILITY; HUMAN; LIVER TOXICITY; PRIORITY JOURNAL; SUBSTANCE ABUSE; WITHDRAWAL SYNDROME;

ALCOHOL-RELATED DISORDERS; CLINICAL TRIALS AS TOPIC; HUMANS; MOLECULAR TARGETED THERAPY; NALTREXONE; NARCOTIC ANTAGONISTS; RECEPTORS, OPIOID; TREATMENT OUTCOME;

EID: 84885462805     PISSN: 11727047     EISSN: 11791934     Source Type: Journal    
DOI: 10.1007/s40263-013-0096-4     Document Type: Article

References (70)

1. Monteiro MG. The road to a world health organization global strategy for reducing the harmful use of alcohol. Alcohol Res Health. 2011;34(2):257-60.
2. Mann K. Pharmacotherapy of alcohol dependence: a review of the clinical data. CNS Drugs. 2004;18(8):485-504.
3. Institute of Medicine. Broadening the base of treatment for alcohol problems. Report of a study by a committee of the Institute of Medicine, Division of Mental Health and Behavioral Medicine. Washington, DC: National Academy Press; 1990.
4. Research Society on Alcoholism. RSA White Paper - Impact of alcoholism and alcohol-induced disease on America, 2011 http://www.rsoa.org/2011-04- 11RSAWhitePaper.pdf
5. Dawson DA, Li TK, Grant BF. A prospective study of risk drinking: at risk for what? Drug Alcohol Depend. 2008;95(1-2):62-72.
6. Rohsenow DJ, Colby SM, Monti PM, Swift RM, Martin RA, Mueller TI, et al. Predictors of compliance with naltrexone among alcoholics. Alcohol Clin Exp Res. 2000;24(10):1542-9.
7. Mann K, Bladstrom A, Torup L, Gual A, van den Brink W. Extending the treatment options in alcohol dependence: a randomized controlled study of as-needed nalmefene. Biol Psychiatry. 2013;73(8):706-13.
8. Gual A, He Y, Torup L, van den Brink W, Mann K. A randomised, double-blind, placebo-controlled, efficacy study of nalmefene, as-needed use, in patients with alcohol dependence. Eur Neuropsychopharmacol. Epub 2013 Apr 03.
9. Emmerson PJ, Liu MR, Woods JH, Medzihradsky F. Binding affinity and selectivity of opioids at mu, delta and kappa receptors in monkey brain membranes. J Pharmacol Exp Ther. 1994;271(3):1630-7.
10. Weerts EM, Kim YK, Wand GS, Dannals RF, Lee JS, Frost JJ, et al. Differences in delta- and mu-opioid receptor blockade measured by positron emission tomography in naltrexone-treated recently abstinent alcohol-dependent subjects. Neuropsychopharmacology. 2008;33(3):653-65.
11. Ingman K, Hagelberg N, Aalto S, Nagren K, Juhakoski A, Karhuvaara S, et al. Prolonged central mu-opioid receptor occupancy after single and repeated nalmefene dosing. Neuropsychopharmacology. 2005;30(12):2245-53.
12. Johnson BA. Update on neuropharmacological treatments for alcoholism: scientific basis and clinical findings. Biochem Pharmacol. 2008;75(1):34-56.
13. Anton RF, O'Malley SS, Ciraulo DA, Cisler RA, Couper D, Donovan DM, et al. Combined pharmacotherapies and behavioral interventions for alcohol dependence: the COMBINE study: a randomized controlled trial. JAMA. 2006;295(17):2003-17.
14. Garbutt JC, Kranzler HR, O'Malley SS, Gastfriend DR, Pettinati HM, Silverman BL, et al. Efficacy and tolerability of long-acting injectable naltrexone for alcohol dependence: a randomized controlled trial. JAMA. 2005;293(13):1617-25.
15. Kranzler HR, Van Kirk J. Efficacy of naltrexone and acamprosate for alcoholism treatment: a meta-analysis. Alcohol Clin Exp Res. 2001;25(9):1335-41.
16. Rösner S, Hackl-Herrwerth A, Leucht S, Vecchi S, Srisurapanont M, Soyka M. Opioid antagonists for alcohol dependence. Cochrane Database Syst Rev 2010;(12):CD001867.
17. O'Malley SS, Sinha R, Grilo CM, Capone C, Farren CK, McKee SA, et al. Naltrexone and cognitive behavioral coping skills therapy for the treatment of alcohol drinking and eating disorder features in alcohol-dependent women: a randomized controlled trial. Alcohol Clin Exp Res. 2007;31(4):625-34.
18. Gueorguieva R, Wu R, Pittman B, Cramer J, Rosenheck RA, O'Malley SS, et al. New insights into the efficacy of naltrexone based on trajectory-based reanalyses of two negative clinical trials. Biol Psychiatry. 2007;61(11):1290-5.
19. Kranzler HR, Wesson DR, Billot L. Naltrexone depot for treatment of alcohol dependence: a multicenter, randomized, placebo-controlled clinical trial. Alcohol Clin Exp Res. 2004;28(7):1051-9.
20. Osborn MD, Lowery JJ, Skorput AG, Giuvelis D, Bilsky EJ. In vivo characterization of the opioid antagonist nalmefene in mice. Life Sci. 2010;86(15-16):624-30.
21. Dixon R, Gentile J, Hsu HB, Hsiao J, Howes J, Garg D, et al. Nalmefene: safety and kinetics after single and multiple oral doses of a new opioid antagonist. J Clin Pharmacol. 1987;27(3):233-9.
22. Dixon R, Howes J, Gentile J, Hsu HB, Hsiao J, Garg D, et al. Nalmefene: intravenous safety and kinetics of a new opioid antagonist. Clin Pharmacol Ther. 1986;39(1):49-53.
23. Mason BJ, Salvato FR, Williams LD, Ritvo EC, Cutler RB. A double-blind, placebo-controlled study of oral nalmefene for alcohol dependence. Arch Gen Psychiatry. 1999;56(8):719-24.
24. Frye RF, Matzke GR, Schade R, Dixon R, Rabinovitz M. Effects of liver disease on the disposition of the opioid antagonist nalmefene. Clin Pharmacol Ther. 1997;61(1):15-23.
25. Michel ME, Bolger G, Weissman BA. Binding of a new opiate antagonist, nalmefene, to rat brain membranes. Methods Find Exp Clin Pharmacol. 1985;7(4):175-7.
26. Schank JR, Goldstein AL, Rowe KE, King CE, Marusich JA, Wiley JL, et al. The kappa opioid receptor antagonist JDTic attenuates alcohol seeking and withdrawal anxiety. Addict Biol. 2012;17(3):634-47.
27. Heinz A, Reimold M, Wrase J, Hermann D, Croissant B, Mundle G, et al. Correlation of stable elevations in striatal mu-opioid receptor availability in detoxified alcoholic patients with alcohol craving: a positron emission tomography study using carbon 11-labeled carfentanil. Arch Gen Psychiatry. 2005;62(1):57-64.
28. 11C]diprenorphine PET study. Eur Neuropsychopharmacol. 2009;19(10):740-8.
29. Wand GS, Weerts EM, Kuwabara H, Wong DF, Xu X, McCaul ME. The relationship between naloxone-induced cortisol and mu opioid receptor availability in mesolimbic structures is disrupted in alcohol dependent subjects. Alcohol. 2012;46(6):511-7.
30. Schluger JH, Ho A, Borg L, Porter M, Maniar S, Gunduz M, et al. Nalmefene causes greater hypothalamic-pituitary-adrenal axis activation than naloxone in normal volunteers: implications for the treatment of alcoholism. Alcohol Clin Exp Res. 1998;22(7):1430-6.
31. Nealey KA, Smith AW, Davis SM, Smith DG, Walker BM. Kappa-opioid receptors are implicated in the increased potency of intra-accumbens nalmefene in ethanol-dependent rats. Neuropharmacology. 2011;61(1-2):35-42.
32. Bart G, Schluger JH, Borg L, Ho A, Bidlack JM, Kreek MJ. Nalmefene induced elevation in serum prolactin in normal human volunteers: partial kappa opioid agonist activity? Neuropsychopharmacology. 2005;30(12):2254-62.
33. Anton RF, Pettinati H, Zweben A, Kranzler HR, Johnson B, Bohn MJ, et al. A multi-site dose ranging study of nalmefene in the treatment of alcohol dependence. J Clin Psychopharmacol. 2004;24(4):421-8.
34. Drobes DJ, Anton RF, Thomas SE, Voronin K. A clinical laboratory paradigm for evaluating medication effects on alcohol consumption: naltrexone and nalmefene. Neuropsychopharmacology. 2003;28(4):755-64.
35. Drobes DJ, Anton RF, Thomas SE, Voronin K. Effects of naltrexone and nalmefene on subjective response to alcohol among non-treatment-seeking alcoholics and social drinkers. Alcohol Clin Exp Res. 2004;28(9):1362-70.
36. Mason BJ, Ritvo EC, Morgan RO, Salvato FR, Goldberg G, Welch B, et al. A double-blind, placebo-controlled pilot study to evaluate the efficacy and safety of oral nalmefene HCl for alcohol dependence. Alcohol Clin Exp Res. 1994;18(5):1162-7.
37. Kranzler HR, Tennen H, Penta C, Bohn MJ. Targeted naltrexone treatment of early problem drinkers. Addict Behav. 1997;22(3):431-6.
38. Heinala P, Alho H, Kiianmaa K, Lonnqvist J, Kuoppasalmi K, Sinclair JD. Targeted use of naltrexone without prior detoxification in the treatment of alcohol dependence: a factorial double-blind, placebo-controlled trial. J Clin Psychopharmacol. 2001;21(3):287-92.
39. Kranzler HR, Armeli S, Tennen H, Blomqvist O, Oncken C, Petry N, et al. Targeted naltrexone for early problem drinkers. J Clin Psychopharmacol. 2003;23(3):294-304.
40. Hernandez-Avila CA, Song C, Kuo L, Tennen H, Armeli S, Kranzler HR. Targeted versus daily naltrexone: secondary analysis of effects on average daily drinking. Alcohol Clin Exp Res. 2006;30(5):860-5.
41. Kranzler HR, Tennen H, Armeli S, Chan G, Covault J, Arias A, et al. Targeted naltrexone for problem drinkers. J Clin Psychopharmacol. 2009;29(4):350-7.
42. Laaksonen E, Koski-Jannes A, Salaspuro M, Ahtinen H, Alho H. A randomized, multicentre, open-label, comparative trial of disulfiram, naltrexone and acamprosate in the treatment of alcohol dependence. Alcohol Alcohol. 2008;43(1):53-61.
43. Karhuvaara S, Simojoki K, Virta A, Rosberg M, Loyttyniemi E, Nurminen T, et al. Targeted nalmefene with simple medical management in the treatment of heavy drinkers: a randomized double-blind placebo-controlled multicenter study. Alcohol Clin Exp Res. 2007;31(7):1179-87.
44. Starosta AN, Leeman RF, Volpicelli JR. The BRENDA model: integrating psychosocial treatment and pharmacotherapy for the treatment of alcohol use disorders. J Psychiatr Pract. 2006;12(2):80-9.
45. Dundon WD, Pettinati HM, Lynch KG, Xie H, Varillo KM, Makadon C, et al. The therapeutic alliance in medical-based interventions impacts outcome in treating alcohol dependence. Drug Alcohol Depend. 2008;95(3):230-6.
46. Mann K, Bladstrom A, Torup L, et al. Shifting the paradigm: reduction of alcohol consumption in alcohol dependent patients: a randomized, double-blind, placebo-controlled study of nalmefene, as needed use. In: European Psychiatric Association (EPA) Congress, Prague 2012; Poster 301-T-944.
47. Mann K, Bladstrom A, Torup L, Gual A, van den Brink W. Shifting the paradigm: ESENSE1 - a randomised, double-blind, placebo-controlled study of nalmefene, as-needed use in alcohol dependent patients. Alcohol Clin Exp Res. 2012;(SI Suppl. 1):246A.
48. Gual A, He Y, Torup L, van den Brink W, Mann K. ESENSE 2: a randomised, double-blind, placebo-controlled study of nalmefene, as-needed use in alcohol dependent patients. Alcohol Clin Exp Res. 2012;36(SI Suppl. 1):246A.
49. van den Brink W, Sorensen P, Torup L, Mann K, Gual A. Long-term efficacy, tolerability and safety of nalmefene as-needed in alcohol dependence: a randomised, double-blind, placebo-controlled study. Alcohol Clin Exp Res. 2012;36(SI Suppl. 1):247A.
50. Matz J, Graff C, Vainio PJ, Kallio A, Hojer AM, Struijk JJ, et al. Effect of nalmefene 20 and 80 mg on the corrected QT interval and T-wave morphology: a randomized, double-blind, parallel-group, placebo- and moxifloxacin-controlled, single-centre study. Clin Drug Investig. 2011;31(11):799-811.
51. Weiss RD, O'Malley SS, Hosking JD, Locastro JS, Swift R. Do patients with alcohol dependence respond to placebo? Results from the COMBINE Study. J Stud Alcohol Drugs. 2008;69(6):878-84.
52. Kranzler HR, Armeli S, Feinn R, Tennen H. Targeted naltrexone treatment moderates the relations between mood and drinking behavior among problem drinkers. J Consult Clin Psychol. 2004;72(2):317-27.
53. Baros AM, Latham PK, Anton RF. Naltrexone and cognitive behavioral therapy for the treatment of alcohol dependence: do sex differences exist? Alcohol Clin Exp Res. 2008;32(5):771-6.
54. Baros AM, Latham PK, Anton RF. Naltrexone and cognitive behavioral therapy for the treatment of alcohol dependence: do sex differences exist? Alcohol Clin Exp Res. 2008;32(5):771-6.
55. Greenfield SF, Pettinati HM, O'Malley S, Randall PK, Randall CL. Gender differences in alcohol treatment: an analysis of outcome from the COMBINE study. Alcohol Clin Exp Res. 2010;34(10):1803-12.
56. Setiawan E, Pihl RO, Cox SM, Gianoulakis C, Palmour RM, Benkelfat C, et al. The effect of naltrexone on alcohol's stimulant properties and self-administration behavior in social drinkers: influence of gender and genotype. Alcohol Clin Exp Res. 2011;35(6):1134-41.
57. Monterosso JR, Flannery BA, Pettinati HM, Oslin DW, Rukstalis M, O'Brien CP, et al. Predicting treatment response to naltrexone: the influence of craving and family history. Am J Addict. 2001;10(3):258-68.
58. Rubio G, Ponce G, Rodriguez-Jimenez R, Jimenez-Arriero MA, Hoenicka J, Palomo T. Clinical predictors of response to naltrexone in alcoholic patients: who benefits most from treatment with naltrexone? Alcohol Alcohol. 2005;40(3):227-33.
59. Krishnan-Sarin S, Krystal JH, Shi J, Pittman B, O'Malley SS. Family history of alcoholism influences naltrexone-induced reduction in alcohol drinking. Biol Psychiatry. 2007;62(6):694-7.
60. Rohsenow DJ, Miranda R Jr, McGeary JE, Monti PM. Family history and antisocial traits moderate naltrexone's effects on heavy drinking in alcoholics. Exp Clin Psychopharmacol. 2007;15(3):272-81.
61. Capone C, Kahler CW, Swift RM, O'Malley SS. Does family history of alcoholism moderate naltrexone's effects on alcohol use? J Stud Alcohol Drugs. 2011;72(1):135-40.
62. Laaksonen E, Lahti J, Sinclair JD, Heinala P, Alho H. Predictors for the efficacy of naltrexone treatment in alcohol dependence: sweet preference. Alcohol Alcohol. 2011;46(3):308-11.
63. Garbutt JC, Osborne M, Gallop R, Barkenbus J, Grace K, Cody M, et al. Sweet liking phenotype, alcohol craving and response to naltrexone treatment in alcohol dependence. Alcohol Alcohol. 2009;44(3):293-300.
64. Bond C, LaForge KS, Tian M, Melia D, Zhang S, Borg L, et al. Single-nucleotide polymorphism in the human mu opioid receptor gene alters beta-endorphin binding and activity: possible implications for opiate addiction. Proc Natl Acad Sci USA. 1998;95(16):9608-13.
65. Oslin DW, Berrettini W, Kranzler HR, Pettinati H, Gelernter J, Volpicelli JR, et al. A functional polymorphism of the mu-opioid receptor gene is associated with naltrexone response in alcohol-dependent patients. Neuropsychopharmacology. 2003;28(8):1546-52.
66. Anton RF, Oroszi G, O'Malley S, Couper D, Swift R, Pettinati H, et al. An evaluation of mu-opioid receptor (OPRM1) as a predictor of naltrexone response in the treatment of alcohol dependence: results from the Combined Pharmacotherapies and Behavioral Interventions for Alcohol Dependence (COMBINE) study. Arch Gen Psychiatry. 2008;65(2):135-44.
67. Arias AJ, Sewell RA. Pharmacogenetically driven treatments for alcoholism: are we there yet? CNS Drugs. 2012;26(6):461-76.
68. Kranzler HR, Armeli S, Covault J, Tennen H. Variation in OPRM1 moderates the effect of desire to drink on subsequent drinking and its attenuation by naltrexone treatment. Addict Biol. 2013;18(1):193-201.
69. Arias AJ, Armeli S, Gelernter J, Covault J, Kallio A, Karhuvaara S, et al. Effects of opioid receptor gene variation on targeted nalmefene treatment in heavy drinkers. Alcohol Clin Exp Res. 2008;32(7):1159-66.
70. Mark TL, Kranzler HR, Poole VH, Hagen CA, McLeod C, Crosse S. Barriers to the use of medications to treat alcoholism. Am J Addict. 2003;12(4):281-94.